NCT00550914已完成不适用
A Multi-Center, Randomized, Controlled Trial of the Pulsed Dye Laser for Juvenile Onset Recurrent Respiratory Papillomatosis
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis
研究概览
简要总结
The purpose of this study is to determine whether the 585-nm pulse dye laser can decrease the time interval between surgeries and improve voice outcomes in children with severe RRP.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Immunocompetent children ages 1-12 with symptomatic JORRP requiring operative intervention
- •Children who have historically required at least four surgeries in the year preceding enrollment to treat laryngeal JORRP
排除标准
- •Children who have required fewer than four procedures to treat laryngeal JORRP in the year prior to enrollment.
- •Children who are currently receiving adjuvant therapies for JORRP including cidofovir, interferon, indole-3-carbinol or Hsp-E
- •Caregivers who are non-English speaking as the PVRQOL instrument has been validated only in the English language.
- •Children whose families do not sign an informed consent to enter into the study.
- •Children whose families anticipate discontinuing care at a participating institution during the study period
结局指标
主要结局
Measure: Time interval between surgical therapy for recurrent respiratory papillomatosis
时间窗: One Year
次要结局
- Measure: Validated voice questionnaire and intraoperative laryngoscopic staging score(One Year)
研究者
研究点 (2)
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